Lidocaine Hydrochloride Jelly (Akorn) – Manufacturing Quality Issues (2022)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Lidocaine Hydrochloride Jelly USP, 2%, Packaged as (a) 5 mL tube (NDC 17478-711-10) x10 per box NDC 17478-711-31; (b) 30 mL tube NDC 17478-711-30; Rx only, Manufactured by: Akorn, Inc., Lake Forest, Il 60045.
Brand
Akorn, Inc.
Lot Codes / Batch Numbers
Lot: (a) 0A02B, 0A02D, 0A02C, 0A02A, 0A02E, EXP 12/31/2022, 0B60C, 0B46B, 0B60D EXP 1/31/2023, 0B67B, 0B67D, 0B60B, 0B60A, 0B67A, 0B46D, 0B67C, 0B46A, EXP 1/31/2023, 0C78B, 0C78D, 0C78C, EXP 2/28/2023, 0D11A, 0D11C, 0D11B, 0D11D, EXP 3/31/2023 0E35C, 0E35B, 0E35A, EXP 4/30/2023, 0J63B, 0J63C, EXP 8/31/2023, 0K02A, 0K02C, 0K02D, 0K02B, EXP 9/30/2023, 0L47B, 0L47C, 0L47A, EXP 10/31/2023, 1B12B, 1B12A, 1B23A, 1B23F, 1B12C, 1B23B, 1B23D, 1B23E, 1B12D, EXP 1/31/2024, 1C66C, 1C66A, EXP 2/29/2024, 1D93B, 1D93D, 1D93C, 1D99B, 1D99C, 1D99A, 1D93A, 1D99D, EXP 3/31/2024 1H96C, 1H96D, 1H96E, EXP 7/31/2024, 1J37B, 1J47B, 1J47D, 1J37C, 1J37A, 1J47C, EXP 8/31/2024, 1L18D, 1L98C, 1L18C, 1L18A, 1L98B, 1L98D, 1L18B, 1L98E, EXP 10/31/2024, 2D21B, EXP 3/31/2025 (b) 0A06A, 0A37A, EXP 12/31/2022, 0B44A, EXP 1/31/2023, 0C88A, 0C84A, EXP 2/28/2023, 0D21A, 0D08A, EXP 3/31/2023, 0E46A, 0E46B, 0E31A, 0E48A, EXP 4/30/2023, 0F72A, 0F58A, EXP 5/31/2023, 0G05A, EXP 6/30/2023, 0H41A, EXP 7/31/2023, 0J67A, 0J67B, EXP 8/31/2023, 0K15B, 0K15A, EXP 9/30/2023, 0L56B, EXP 10/31/2023, 1B20A, EXP 1/31/2024, 1C47A, 1C52A, EXP 2/29/2024, 1D84B, 1D84A, EXP 3/31/2024, 1G61A, 1G64A, 1G72A, EXP 6/30/2024, 1J51A, 1J28A, EXP 8/31/2024, 1K63A, 1K69A, 1K73A, 1K69B, 1K69C, EXP 9/30/2024, 1L15B, EXP 10/31/2024, 2C08A, EXP 2/28/2025
Products Sold
Lot: (a) 0A02B, 0A02D, 0A02C, 0A02A, 0A02E, EXP 12/31/2022; 0B60C, 0B46B, 0B60D EXP 1/31/2023; 0B67B, 0B67D, 0B60B, 0B60A, 0B67A, 0B46D, 0B67C, 0B46A, EXP 1/31/2023; 0C78B, 0C78D, 0C78C, EXP 2/28/2023; 0D11A, 0D11C, 0D11B, 0D11D, EXP 3/31/2023 0E35C, 0E35B, 0E35A, EXP 4/30/2023; 0J63B, 0J63C, EXP 8/31/2023; 0K02A, 0K02C, 0K02D, 0K02B, EXP 9/30/2023; 0L47B, 0L47C, 0L47A, EXP 10/31/2023; 1B12B, 1B12A, 1B23A, 1B23F, 1B12C, 1B23B, 1B23D, 1B23E, 1B12D, EXP 1/31/2024; 1C66C, 1C66A, EXP 2/29/2024; 1D93B, 1D93D, 1D93C, 1D99B, 1D99C, 1D99A, 1D93A, 1D99D, EXP 3/31/2024 1H96C, 1H96D, 1H96E, EXP 7/31/2024; 1J37B, 1J47B, 1J47D, 1J37C, 1J37A, 1J47C, EXP 8/31/2024; 1L18D, 1L98C, 1L18C, 1L18A, 1L98B, 1L98D, 1L18B, 1L98E, EXP 10/31/2024; 2D21B, EXP 3/31/2025 (b) 0A06A, 0A37A , EXP 12/31/2022; 0B44A, EXP 1/31/2023; 0C88A, 0C84A, EXP 2/28/2023; 0D21A, 0D08A, EXP 3/31/2023; 0E46A, 0E46B, 0E31A, 0E48A, EXP 4/30/2023; 0F72A, 0F58A, EXP 5/31/2023; 0G05A, EXP 6/30/2023; 0H41A, EXP 7/31/2023; 0J67A, 0J67B, EXP 8/31/2023; 0K15B, 0K15A, EXP 9/30/2023; 0L56B, EXP 10/31/2023; 1B20A, EXP 1/31/2024; 1C47A, 1C52A, EXP 2/29/2024; 1D84B,1D84A, EXP 3/31/2024; 1G61A, 1G64A, 1G72A, EXP 6/30/2024; 1J51A, 1J28A, EXP 8/31/2024; 1K63A, 1K69A, 1K73A, 1K69B, 1K69C, EXP 9/30/2024; 1L15B, EXP 10/31/2024; 2C08A,EXP 2/28/2025;
Akorn, Inc. is recalling Lidocaine Hydrochloride Jelly USP, 2%, Packaged as (a) 5 mL tube (NDC 17478-711-10) x10 per box NDC due to CGMP Deviations:. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
CGMP Deviations:
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026